Fluid injection system having various systems for controlling an injection procedure

ABSTRACT

A fluid injection system that includes an injector head having a syringe for delivering a fluid to a patient; a mounting structure pivotally connected to the injector head and configured to support the injector head above a surface; and a control system operationally coupled to the injector head for controlling an injection procedure is disclosed. The fluid injection system is provided with various sensors to control various aspects of the fluid injection system, such as the establishment of a reference plane, the determination of a tilt angle of the injector head, and the determination of a temperature of an actuation system of the injector head.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 61/485,238, entitled “Fluid Injection System HavingVarious Systems for Controlling an Injection Procedure”, filed May 12,2011, the disclosure of which is incorporated herein by reference in itsentirety.

BACKGROUND OF THE INVENTION Field of the Invention

The devices of the present disclosure relate generally to fluidinjection systems for supplying fluids during medical and therapeuticprocedures and, more specifically, for controlling the fluid suppliedduring an angiographic injection procedure.

Description of Related Art

In many medical diagnostic and therapeutic procedures, a physician orother person injects a patient with a fluid. In recent years, a numberof injector-actuated syringes and powered injectors for pressurizedinjection of fluids, such as contrast media, have been developed for usein procedures such as angiography, computed tomography, ultrasound, andNMR/MRI. In general, these powered injectors are designed to deliver apreset amount of contrast media at a preset flow rate. Angiography isused generally in the diagnosis and therapeutic treatment ofabnormalities in blood vessels. In an angiographic procedure, aradiographic image of vascular structure is obtained through the use ofa radiographic contrast medium, sometimes referred to simply ascontrast, injected through a catheter. The vascular structures areinjected and filled with contrast. X-rays passing through the region ofinterest are absorbed by the contrast, causing a radiographic image ofthe blood vessels. The resulting images can be displayed on, forexample, a monitor and recorded.

In a typical angiographic procedure, a physician places a catheter intoa vein or artery. The catheter is connected to either a manual or to anautomatic contrast injection mechanism. A typical manual contrastinjection mechanism includes a syringe in fluid connection with acatheter. The fluid path also includes, for example, a source ofcontrast fluid, a source of saline, and a pressure transducer to measurepatient blood pressure. In a typical system, the source of contrast isconnected to the fluid path via a valve, for example, a three-waystopcock. The source of saline and pressure transducer P may also beconnected to the fluid path via additional valves. The operator of themanual system manually controls the syringe and each of the valves todraw saline or contrast into the syringe and to inject the saline orcontrast into the patient through the catheter connection.

The operator of the syringe may adjust the flow rate, or simply known asflow, and volume of injection by altering the force applied to theplunger of the syringe. Manual sources of fluid pressure and flow usedin medical applications, such as syringes and manifolds thus typicallyrequire operator effort that provides feedback of the fluidpressure/flow generated to the operator. The feedback is desirable, butthe operator effort often leads to fatigue. Thus, fluid pressure andflow may vary depending on the operator's strength and technique.

Automatic contrast injection mechanisms typically include a syringeconnected to a powered injector having, for example, a powered linearactuator. Typically, an operator enters settings into an electroniccontrol system of the powered injector for a fixed volume of contrastmaterial and a fixed rate of injection. In many systems, there is nointeractive control between the operator and the powered injector,except to start or stop the injection. A change in flow rate in suchsystems occurs by stopping the machine and resetting the parameters.Automation of angiographic procedures using powered injectors isdiscussed, for example, in U.S. Pat. Nos. 5,460,609, 5,573,515, and5,800,397.

U.S. Pat. No. 5,800,397, for example, discloses an angiographic injectorsystem having high pressure and low pressure systems. The high pressuresystem includes a motor-driven injector pump to deliver radiographiccontrast material under high pressure to a catheter. The low pressuresystem includes, among other things, a pressure transducer to measureblood pressure and a pump to deliver a saline solution to the patient aswell as to aspirate waste fluid. A manifold is connected to the syringepump, the low pressure system, and the patient catheter. A flow valveassociated with the manifold is normally maintained in a first stateconnecting the low pressure system to the catheter through the manifold,and disconnecting the high pressure system from the catheter and the lowpressure system. When pressure from the syringe pump reaches apredetermined and set level, the valve switches to a second stateconnecting the high pressure system/syringe pump to the catheter, whiledisconnecting the low pressure system from the catheter and from thehigh pressure system. However, the arrangement of the system componentsof U.S. Pat. No. 5,800,397 results in relatively large amounts of wastedcontrast and/or undesirable injection of an excessive amount of contrastwhen the low pressure, typical saline system, is used.

Unlike manual injection systems, however, there is little if anyfeedback to the operator of system pressure in the systems disclosed inthe U.S. patents identified previously. There are potential advantagesto such feedback. In the use of a manual syringe, for example, excessiveback pressure on the syringe plunger can provide evidence of occlusionof the fluid path.

While manual and automated injectors are known in the medical field, aneed generally exists for improved fluid injection systems adapted foruse in medical diagnostic and therapeutic procedures where fluids aresupplied to a patient during the procedure. A specific need generallyexists for an improved fluid injection system for use in fluid injectionprocedures, such as angiography. Moreover, a continuing need exists inthe medical field to generally improve upon known medical devices andsystems used to supply fluids to patients during medical procedures,such as angiography, computed tomography, ultrasound, and NMR/MRI.

SUMMARY

According to one aspect of the device of the present disclosure,provided is a fluid injection system that includes: an injector head fordelivering a fluid to a patient; a mounting structure pivotallyconnected to the injector head and configured to mount the injector headto an examination table; a reference plane sensor positioned within theinjector head for determining an orientation of the injector headrelative to the mounting structure; and a control system operationallycoupled to the injector head and the reference plane sensor forcontrolling an injection procedure. The control system is configured toreceive an input from the reference plane sensor to establish areference plane with respect to a floor surface and alert a user if anoffset that is detrimental to air management exists between thereference plane and the floor surface.

The control system may be operationally coupled to a display unit havinga graphical user interface. The user may be alerted that an offsetexists between the reference plane and the floor surface by a messageappearing on the graphical user interface of the display unit. Thedisplay unit may be mounted to a rail of the examination table by anadditional mounting structure.

The mounting structure may include a clamping mechanism removablycoupled to a rail of the examination table, a pole extending from theclamping mechanism above the examination table, and a support arm havinga first end pivotally coupled to the pole and a second end pivotallycoupled to the injector head. If the user is alerted that an offsetexists between the reference plane and the floor surface, the user mayreposition the injector head by rotating the injector head around thesecond end of the support arm until the reference plane sensorestablishes a new reference plane that is parallel to the floor surface.

Desirably, a reference plane sensor is a 3-axis accelerometer. Inaddition, the injector head may include a housing having a display on atop portion thereof.

According to another aspect of the device of the present disclosure,provided is a fluid injection system that includes: an injector head fordelivering a fluid to a patient; a mounting structure having a supportarm with a first end coupled to a generally vertically extendingmounting pole and a second end pivotally coupled to the injector head bya pivoting knuckle; a display for displaying information regarding theactivities and state of operation of the injector head; a potentiometerpositioned within the knuckle for generating a tilt angle signalindicative of an angle of tilt of the injector head relative to themounting pole; and a control circuit connected to the injector head, thepotentiometer, and the display for controlling delivery of the fluid tothe patient, for generating display information and delivering thedisplay information to the display, and for receiving the tilt anglesignal from the potentiometer. The display is responsive to the tiltangle signal to display the display information in a first orientationin response to a first range of values of the tilt angle signal, and todisplay the display information in a second orientation in response to asecond range of values of the tilt angle signal.

The display may be positioned on a housing of the injector head. Thedisplay may be configured to display information regarding volumeremaining, flow rate, pressure, programmed volume, or any combinationthereof. The control system may be operationally coupled to anadditional display having a graphical user interface. The additionaldisplay may be located remotely from the injector head. The additionaldisplay may be pivotally mounted to the mounting pole by an additionalsupport arm. The control system may be configured to prevent aninjection if the tilt angle signal is received from the potentiometerand indicates that the injector head is tilted upwardly.

According to yet another aspect of the device of the present disclosure,provided is a fluid injection system that includes: an injector head fordelivering a fluid to a patient; a plurality of sensors positionedwithin the injector head for generating signals indicative of the statusof the injector head; a control system operationally coupled to theinjector head and the plurality of sensors for controlling an injectionprocedure; and a display unit operationally coupled to the controlsystem. Based on the signals generated by the plurality of sensors, thecontrol system generates a list of actions on the display unit that mustbe completed by a user before the injector head can be armed to performthe injection procedure. In addition, as one of the plurality of sensorsdetermines that the user has completed an action from the list ofactions, the action may be removed from the list of actions on thedisplay unit. The list of actions may include at least one of thefollowing actions: load syringe, engage drop front, advance plunger,rotate injector head down to arm, rotate syringe and remove, disconnectpatient, flow rate reduced, calibration needed, rotate head up andpurge, injection complete, procedure halt—display touch, procedurehalt—head touch, procedure halt—start switch, procedure halt—ISI, andprocedure halt—low volume.

A mounting structure may be pivotally connected to the injector head andconfigured to support the injector head. The mounting structureincludes: a mobile base positioned on the floor; a pole extending fromthe mobile base above the floor; and a first support arm having a firstend pivotally coupled to the pole and a second end pivotally coupled tothe injector head. The mounting structure may further include a secondsupport arm having a first end pivotally coupled to the pole and asecond end pivotally coupled to the display unit. The display unit maybe a graphical user interface for allowing a user to control aninjection procedure and for displaying the list of actions.

The injector head may include a housing having a display on a topportion thereof. The housing of the injector head may include a handleextending therefrom for allowing a user to manipulate the injector head.

According to still another aspect of the device of the presentdisclosure, provided is a fluid injection system that includes aninjector head for delivering a fluid to a patient. The injector headincludes: a housing; a mechanical interface on a front face of thehousing for receiving a disposable syringe; a piston positioned withinthe housing for connecting to a plunger of the disposable syringe; andan actuation system positioned within the housing for moving the piston.The fluid injection system also includes: at least one temperaturesensor positioned in the vicinity of the actuation system within thehousing of the injector head for generating signals indicative of thetemperature of the actuation system; and a control system operationallycoupled to the injector head and the at least one temperature sensor forcontrolling an injection procedure. The control system inhibitsoperation of the actuation system if a temperature determined by the atleast one temperature sensor exceeds a predefined threshold level.

The actuation system may include: a gear train and linear ball screw; abrushless DC motor coupled to the gear train and linear ball screw; anda motor amplifier operationally coupled to the motor. The control systemmay be operationally coupled to a display unit having a graphical userinterface. A user may be alerted that the temperature determined by theat least one temperature sensor exceeds the predefined threshold levelby a message appearing on the graphical user interface of the displayunit.

According to yet another aspect of the device of the present disclosure,provided is a syringe for use with each of the above-described fluidinjection systems. The syringe includes a body having a distal end and aproximal end and a center section therebetween. The distal end includesan injection section having a conical portion that extends and tapersfrom the center section to an injection neck forming a discharge outletand the proximal end includes a radial expansion section having areduced wall thickness such that an inner diameter of the radialexpansion section is larger than an inner diameter of the center sectionand the outer diameter of the radial expansion section is smaller thanan outer diameter of the center section. The syringe also includes aplunger movably disposed in the body and having a coupling end. Theplunger is substantially seated in the radial expansion section in apre-use state of the syringe. In addition, an alignment flange is formedon the conical portion and extends the distance between the centersection and the injection neck. The alignment flange is generallyrectangular in shape and defines an internal hollow area therein influid communication with the interior of the body.

These and other features and characteristics of the device of thepresent disclosure, as well as the methods of operation and functions ofthe related elements of structures and the combination of parts andeconomies of manufacture, will become more apparent upon considerationof the following description and the appended claims with reference tothe accompanying drawings, all of which form a part of thisspecification, wherein like reference numerals designate correspondingparts in the various figures. It is to be expressly understood, however,that the drawings are for the purpose of illustration and descriptiononly and are not intended as a definition of the limits of the device ofthe present disclosure. As used in the specification and the claims, thesingular form of “a”, “an”, and “the” include plural referents unlessthe context clearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a fluid injection system in accordancewith the device of the present disclosure;

FIG. 1B is a perspective view of the fluid injection system of FIG. 1Amounted to the rail of an examination table;

FIG. 2 is a schematic block diagram of the fluid injection system ofFIG. 1A;

FIG. 3 is a right-side perspective view of an injector head of the fluidinjection system of FIG. 1A;

FIG. 4 is a left-side perspective view of the injector head of FIG. 3;

FIG. 5 is an exploded perspective view of a pressure jacket and wiperseal for use therewith in accordance with the device of the presentdisclosure;

FIG. 6 is an assembled perspective view of the pressure jacket and wiperseal of FIG. 5;

FIG. 7 is a top plan view of the pressure jacket of FIG. 5;

FIG. 8 is a portion of the pressure jacket of FIG. 7 enlarged formagnification purposes;

FIG. 9 is a cross-sectional view of the pressure jacket positionedwithin the syringe support structure in accordance with the device ofthe present disclosure;

FIG. 10 is a portion of the pressure jacket and syringe supportstructure of FIG. 9 enlarged for magnification purposes;

FIG. 11 is a side plan view of a faceplate of the injector head inaccordance with the device of the present disclosure;

FIG. 12 is a cross-sectional view of the faceplate of FIG. 11 takenalong line 12-12;

FIG. 13 is a cross-sectional view of the pressure jacket positionedwithin the syringe support structure in accordance with the device ofthe present disclosure;

FIG. 14 is a portion of the pressure jacket and syringe supportstructure of FIG. 13 enlarged for magnification purposes;

FIG. 15 is a perspective view of a snap ring provided for securing thepressure jacket to an injector housing of the injector head inaccordance with the device of the present disclosure;

FIG. 16 is a side plan view of the snap ring of FIG. 15;

FIG. 17 is a cross-sectional view of the snap ring of FIG. 15 takenalong line 17-17;

FIG. 18 is a top plan exploded view of a syringe for use with the fluidinjection system in accordance with the device of the presentdisclosure;

FIG. 19 is an assembled perspective view of a portion of the syringe ofFIG. 18;

FIG. 20 is an assembled top plan view of a portion of the syringe ofFIG. 18;

FIG. 21 is a perspective view of the syringe of FIG. 18 with a plungermember and a connector removed therefrom;

FIG. 22 is a perspective view of an alternative embodiment of thesyringe in accordance with the device of the present disclosure in whichthe coupling members of the plunger member are positioned parallel to analignment flange on the syringe body;

FIG. 23 is a cross-sectional view taken along line 23-23 in FIG. 21;

FIG. 24 is a cross-sectional view taken along line 24-24 in FIG. 21;

FIG. 25 is a perspective view of the connector of the syringe of FIG. 18coupled to a tubing set in accordance with the device of the presentdisclosure;

FIG. 26 is a right-side perspective view of the injector head of thefluid delivery system in accordance with another embodiment of thedevice of the present disclosure;

FIG. 27 is an exploded perspective view of a syringe support structureillustrating a splash shield in accordance with the device of thepresent disclosure;

FIG. 28 is an assembled perspective view of the syringe supportstructure of FIG. 27;

FIG. 29 is a right-side perspective view of the injector head of FIG. 3with the injector housing removed;

FIG. 30 is a left-side perspective view of the injector head of FIG. 4with the injector housing removed;

FIG. 31 is a side plan view of a knuckle of a mounting structure for theinjector head of FIG. 3 when the injector head is in an inject position;

FIG. 32 is a cross-sectional view of the knuckle taken along line 32-32in FIG. 31;

FIG. 33 is a side plan view of a knuckle of a mounting structure for theinjector head of FIG. 3 when the injector head is in a fill position;

FIG. 34 is a cross-sectional view of the knuckle taken along line 34-34in FIG. 33;

FIG. 35 is a side plan view of a knuckle of a mounting structure for theinjector head of FIG. 3 when the injector head is in a level position;

FIG. 36 is a cross-sectional view of the knuckle taken along line 36-36in FIG. 35;

FIG. 37 is a side plan view of the knuckle and the injector head in theinject position;

FIG. 38 is a side plan view of the knuckle and the injector head in thefill position;

FIG. 39 is a side plan view of the knuckle and the injector head in thelevel position;

FIG. 40 illustrates the ranges of a tilt angle for the injector head inaccordance with the device of the present disclosure;

FIGS. 41 and 42 are respective graphical user interface displayspresented to an operator during use of the fluid injection system inaccordance with the device of the present disclosure;

FIG. 43 is a right-side perspective view of a portion of the injectorhead of the fluid delivery system in accordance with another embodimentof the device of the present disclosure;

FIG. 44 is a front right side exploded perspective view of the portionof the injector head of the fluid delivery system of FIG. 43;

FIG. 45 is a rear right side exploded perspective view of the portion ofthe injector head of the fluid delivery system of FIG. 43; and

FIG. 46 is a front plan view of a portion of the injector head of thefluid delivery system of FIG. 43 with one of the pressure jacketassemblies removed therefrom.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof, shall relate to the device ofthe present disclosure as it is oriented in the drawing figures.However, it is to be understood that the device of the presentdisclosure may assume various alternative variations, except whereexpressly specified to the contrary. It is also to be understood thatthe specific devices illustrated in the attached drawings, and describedin the following specification, are simply exemplary embodiments of thedevice of the present disclosure. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

The injector disclosed herein is related to the injector disclosed inU.S. Pat. Nos. 7,326,189; 7,334,639; 7,549,977; 7,556,619; 7,563,249;and 7,611,503 and United States Patent Application Publication No.2008/0086087, which are hereby incorporated by reference in theirentirety.

With reference to FIGS. 1A and 2, a fluid injection system, generallydenoted as reference numeral 1, includes an injector head 3 fordelivering a fluid to a patient 5; a mounting structure 7 pivotallyconnected to the injector head 3 and configured to support the injectorhead 3; and a control system, including a display control unit (DCU) 9,operationally coupled to the injector head 3 for controlling aninjection procedure. The DCU 9 includes a color liquid crystal display(LCD) screen with a touch screen overlay that is interfaced to aninternal computer board. The DCU 9 is responsible for providing agraphical user interface (GUI) to the user and allows information to beinput via the touch screen to the control system.

In addition, the injection system 1 can support multiple display DCUs,such as auxiliary DCU 11 shown in FIG. 2. When multiple DCUs areincorporated into the injection system 1, the multiple DCUs are notoperated in a master/slave configuration. Instead, a user may interfacewith any of multiple input devices such as the display controls(discussed hereinafter) of the injector head 3 or any of the multipleDCUs 9, 11. While the user is interacting with one of these inputdevices, control inputs from the others are ignored (i.e., locked).However, their display outputs can be updated by the active inputdevice. When the user has returned to the Home screen of a DCU, the lockon all input devices is removed. Another way in which control may begiven up and the lock removed, is through the use of timeouts. If theinterface device is not interacted with by the user for a period of time(5 seconds for injector head inputs, 30 seconds for DCU inputs), anaudible or visual indicator is asserted and control is given up by theactive input device.

FIG. 1A illustrates the injection system 1 provided as a mobile unit andFIG. 1B illustrates the injection system 1 as being mounted to anexamination table 13. In each configuration, the mounting structure 7 ofthe fluid injection system 1 includes a first support arm 15 extendingfrom a support column 17 for supporting the DCU 9. A second support arm19 extends from the support column 17 and generally supports theinjector head 3. The second support arm 19 has a first end 18 pivotallycoupled to the support column 17 and a second end 20 pivotally coupledto a knuckle 22 of the injector head 3.

In the configuration shown in FIG. 1B, the support column 17 isassociated with a rail interface 21 which is generally adapted to attachthe fluid injection system 1 to a hospital bed or an examination table13 supported by a stand 12. Alternatively, and as shown in FIG. 1A, thesupport column 17 may include a pedestal interface 23 for attaching thefluid injection system 1 to a movable pedestal 25. The fluid injectionsystem 1 may be configured to be attached to the examination table 13 orthe movable pedestal 25 to provide the maximum amount of flexibility andease in utilizing the fluid injection system 1. Thus, when the fluidinjection system 1 is mounted to the examination table 13, a rail mount27 is attached to a rail 29 of the examination table 13. This allows therail interface 21 to be removably attached to the rail mount 27. Thus,the rail mount 27 indirectly supports the DCU 9 and the injector head 3.In an alternative embodiment, only the injector head 3 is indirectlysupported by the rail mount 27, and an additional rail mount is utilizedto independently support the DCU 9 at a different location on the rail29 of the examination table 13.

Referring to FIG. 1A, the movable pedestal 25 provides mobility to thefluid injection system 1 and height adjustability features. The movablepedestal 25 includes a base 31 for holding loose components related tothe fluid injection system 1 and the power cables associated therewith.The base 31 may also include a power socket (not shown) that interfaceswith the power cables (not shown) within the base 31. Thus, a singleexternal power cable (not shown) may be plugged directly into the powersocket (not shown) to provide sufficient power for operation of theentire fluid injection system 1. The movable pedestal 25 may alsoinclude a plurality of casters 33 having lockable brakes 35 and wheels37. It is to be understood that the aforementioned configurations arefor exemplary purposes only and are not to be considered as limiting theplacement and positioning of the fluid injection system 1.

With reference to FIG. 2, the fluid injection system 1 also includes apower supply unit 39 operationally coupled to the injector head 3, theDCU 9, and the optional auxiliary DCU 11. The power supply unit 39houses power conversion devices (not shown) for converting domestic andinternational standardized commercial AC line voltages 41 into internal+15 and +48V DC power for the fluid injection system 1. The power supplyunit 39 is coupled to the commercial AC line voltages 41 by a plug 43.In addition, the power supply unit 39 houses an Ethernet switch card(not shown). The switch card serves as the communications hub for theentire system. Ethernet communications data 45 is passed to the switchcard and routed to the appropriate recipients. An Imaging SystemsInterface (ISI) module 47 is also housed in the power supply unit 39.The ISI module 47 allows the fluid injection system 1 to connect to acommon commercial X-Ray scanner 49.

The fluid injection system 1 may further include a hand or foot switch51 provided to initiate an injection. The hand/foot switch 51 can beconnected to either the DCU (primary 9 or auxiliary 11) or the powersupply unit 39. If a foot switch is utilized, it is designed to beplaced on the floor for foot activation.

With reference to FIGS. 3 and 4 and with continued reference to FIGS. 1Aand 2, injector head 3 includes an injector housing 53 having a frontend 55 and a back end 56. A faceplate 57 is attached to the front end 55of the injector housing 53 and encloses the front end 55 of the injectorhousing 53. The faceplate 57 may be secured to the front end 55 of theinjector housing 53 by conventional means (i.e., mechanical fastenersand the like) or be integrally formed with the injector housing 53.

The injector housing 53 has a central opening 59 aligned with a centralpassage defined by the faceplate 57, and through which an injector drivepiston of the injector head 3 is extendable and retractable. The detailsof the injector head 3 and, more particularly, the injector drive pistonare described in U.S. Pat. No. 5,383,858, which is incorporated byreference herein in its entirety. As described further herein, theinjector head 3 is generally used to actuate a syringe 61 used in afluid injection procedure, such as an angiographic procedure.

With reference to FIGS. 5-8 and with continued reference to FIGS. 3 and4, a pressure jacket assembly, generally denoted as reference numeral63, is associated with the injector head 3. The pressure jacket assembly63 supports the syringe 61 and mounts the syringe 61 to the injectorhead 3. Generally, the pressure jacket assembly 63 extends outward fromthe front end 55 of the injector housing 53 and is used to support thesyringe 61 during the fluid injection procedure. The pressure jacketassembly 63 is generally comprised of the faceplate 57, discussedpreviously, a cylindrical pressure jacket 65 having a coupling end 67for connecting the pressure jacket 65 to the faceplate 57, and a syringesupport structure 69 for supporting the syringe 61. The faceplate 57 maybe considered to be a part of the injector housing 53, as well as formpart of the pressure jacket assembly 63.

The pressure jacket 65 is a generally cylindrical structure having afront or distal end 71 and the rear coupling end 67. The distal end 71of the pressure jacket 65 defines a syringe receiving mouth or opening122 for receiving the syringe 61 into the pressure jacket 65. An outeredge of the distal end 71 of the pressure jacket 65 includes a groovedinterface 124 configured to receive a wiper seal 126. The wiper seal 126is positioned within the grooved interface 124 of the pressure jacket 65as shown in FIGS. 5 and 6. The purpose of the wiper seal 126 is toreduce the amount of contrast passing into the small gap (not shown)between the pressure jacket 65 and the syringe 61 when the syringe 61 isloaded into and/or unloaded from the pressure jacket 65. When contrastgets onto the inside wall of the pressure jacket 65, it makes itdifficult to insert the syringe 61 and it is detrimental to visibilityof the contents of the syringe 61. The gap between the pressure jacket65 and the syringe 61 is necessary to accommodate the tolerancesassociated with each part. During high pressure injection procedures,the syringe 61 swells up and contacts the inside of the pressure jacket65 thus gaining additional support from the pressure jacket 65. Thewiper seal 126 includes a generally ring-shaped body 128 that isdesigned to be flexible in nature to accommodate the manufacturingvariation in the syringe 61 as well as the swelling that occurs duringhigh pressure injections. The ring-shaped body 128 of the wiper seal 126is designed to follow the outer edge at the opening 122 of the pressurejacket 65. It is custom molded to follow the exact 22 degree bevelcontained on the pressure jacket 65 (see FIGS. 9 and 10) and is taperedto help the user align and insert the syringe 61 into the pressurejacket 65.

The coupling end 67 of the pressure jacket 65 faces the faceplate 57 andis configured to be connected to the faceplate 57. The coupling end 67of the pressure jacket 65 is designed such that it allows the pressurejacket 65 to be installed by simply pushing it axially into the centralopening 59 of the faceplate 57 of the injector head 3. The coupling end67 of the pressure jacket 65 includes a locating slot 130, a rampedsurface 132, and a groove 134. The locating slot 130 is provided toallow a user to properly align the pressure jacket 65 with the faceplate57 by aligning the locating slot 130 with a notch 136 provided in thecentral opening 59 of the faceplate 57 as shown in FIG. 12. Withreference to FIGS. 11-17 and with continued reference to FIGS. 5-8, theramped surface 132 and groove 134 are designed to interact with a snapring 138 provided in the central opening 59 of the faceplate 57 in orderto secure the pressure jacket 65 to the faceplate 57. The snap ring 138includes a generally ring-shaped body member 140 having a locating slot142 provided in an upper portion thereof. The locating slot 142 isconfigured to be aligned with the notch 136 of the central opening 59 ofthe faceplate 57 when the snap ring 138 is positioned within the centralopening 59 as shown in FIG. 12.

As the pressure jacket 65 is pushed into the central opening 59, thesnap ring 138 located within the central opening 59 rides up over theramped surface 132 of the coupling end 67 of the pressure jacket 65 anddrops into the groove 134. The snap ring 138 provides sufficient inwardradial force to hold the pressure jacket 65 in the desired position.Upon removal, the snap ring 138 again rides up over the ramped surface132 of the coupling end 67 of the pressure jacket 65 and completelydisengages from the pressure jacket 65. This bayonet design has twodistinct advantages. First, the user can install and remove the pressurejacket 65 without the use of tools or excessive force. This isbeneficial because it allows the user to easily remove the pressurejacket 65 for cleaning and then reinstall it. Secondly, it allows thepressure jacket 65 to move axially during a high pressure injection.This is important because during a high pressure injection, the entiresyringe interface stretches forward due to the extreme forces. Thesyringe 61 swells up inside the pressure jacket 65 contacting the insidewall of the pressure jacket 65. Due to the friction between the syringe61 and the pressure jacket 65, the pressure jacket 65 is pulled forwardalong with the syringe 61. If the interface between the pressure jacket65 and the injector head 3 does not permit this axial motion during highpressure injections, relative motion between the syringe 61 and pressurejacket 65 occurs. This relative motion causes an undesirable stick-slipphenomenon between the syringe 61 and the pressure jacket 65.

The pressure jacket 65 has an inner diameter sized to smoothly butsnugly receive the outer diameter of the syringe 61. The pressure jacket65 is desirably made of a material capable of restraining the outwardexpansion of the syringe 61 during an injection procedure. The syringe61 by itself is typically not capable of withstanding the high pressuresassociated with certain fluid injection procedures, such as angiography.The syringe 61 may be made of a relatively inexpensive medical gradeplastic material and may be disposable (i.e., single use).Alternatively, the syringe 61 may be a multi-patient use syringe.Typical plastics for the syringe 61 include polypropylene, polyethylene,and polycarbonate. The pressure jacket 65 is desirably reusable and madeof a material capable of withstanding pressures up to about 1200 psi andhigher. For example, the pressure jacket 65 may be made of metal, suchas steel or aluminum. However, as explained further hereinafter, it isadvantageous for the syringe 61 to be visible through the pressurejacket 65 so that an operator of the fluid injection system 1 may viewthe syringe 61 during an injection procedure. Accordingly, the pressurejacket 65 is preferably made of a substantially clear plastic material,such as polycarbonate, for viewing the syringe 61 during an injectionprocedure.

An alternate to the use of an integrally formed coupling end 67 at theend of the pressure jacket 65 for connecting the pressure jacketassembly 63 to the injector head 3, a separate coupling member (notshown) may be utilized. The coupling member may be used in place of thecoupling end 67 and is cylindrically shaped in a similar manner to thepressure jacket 65. The coupling member has a front or distal endconfigured for connection to the pressure jacket 65 and a rear orproximal end configured for connection to the faceplate 57. The couplingmember may be made of any of the materials discussed previously inconnection with the pressure jacket 65.

With specific reference to FIGS. 18-25, the syringe 61 used in the fluidinjector system 1 generally includes an elongated, cylindrical syringebody 74 having a front or distal end 75 and a rear or proximal end 76.The syringe body 74 has an injection section 78 formed at the distal end75. As discussed further hereinafter, the syringe body 74 includes anexpansion section 150 at the proximal end 76. A generally cylindricalcenter section or main body 152 of the syringe body 74 connects theinjection section 78 and the expansion section 150. The main body 152has a relatively uniform outer diameter. The injection section 78 tapersto form an elongated injection neck 77, which has a relatively smallinner diameter compared to the inner diameter of the main body 152. Theinjection section 78, injection neck 77 generally forms the dischargeoutlet of the syringe 61. The syringe support structure 69 is configuredto support the injection section 78 of the syringe 61. The injectionneck 77 includes a distal end structure, which is adapted to connect viaa suitable luer fitting to tubing, for example, connected to a catheterused in an angiographic procedure, as discussed in greater detailhereinafter. A suitable luer fitting for this purpose is disclosed inpublished PCT Application No. PCT/US99/18892 (WO 00/10629), entitled“Connector And Tubing Assembly For Use With A Syringe”, the disclosureof which is incorporated herein by reference in its entirety. Moredesirably, the distal end structure will include a connector asdiscussed in greater detail hereinafter.

Additional features of the syringe 61 will now be discussed withcontinuing reference to FIGS. 19-26. The injection section 78 of thesyringe body 74 generally tapers inward toward a central axis L of thesyringe body 74. The injection section 78 includes a conical portion 154tapering from the cylindrical shaped center section or main body 152 tothe injection neck 77. The conical portion 154 defines an alignmentflange or tab member 156. This alignment flange or tab member 156, inone embodiment, defines a hollow space or area therein. The alignmentflange or tab member 156 is provided as a means to view the fluid withinthe syringe 61. Additionally, the alignment flange or tab member 156acts as a visual indicator for properly aligning the syringe 61 in thepressure jacket 65. Further, the alignment flange or tab member 156provides a convenient handle for manipulating the syringe 61 andinserting it into the pressure jacket 65. Secondarily, the hollow spacedefined by the alignment flange 156 may operate as an air bubble trap.Desirably, the alignment flange or tab member 156 generally extends thedistance between the main body 152 of the syringe body 74 and theinjection neck 77.

A plunger member 158 is slidably supported within the syringe body 74.The plunger member 158 may include a plunger core 160 that is moldedfrom a hard polymeric material, for example, polycarbonate material. Aseal or plunger cover 162 is also attached to the plunger core 160. Theplunger member 158 is configured for connection to an injector drivepiston (not shown) for imparting motive forces thereto. The plunger core160 includes a coupling end 164 that faces the proximal end 76 of thesyringe body 74 and is configured to engage the injector drive piston.The coupling end 164 includes a pair of flexible lug or coupling members227 that extend outward from the coupling end 164 for engaging theinjector drive piston. The coupling members 227 each have an engagementarm 228. The coupling members 227 define a slot 230 therebetween. Theslot 230 is configured to receive an injector end plate attached to theinjector drive piston. As mentioned hereinabove, the alignment flange ortab member 156 provides a last resort air containment feature when thedistal end of the plunger member 158 extends into and “bottoms-out” inthe conical portion 154. Any unnoticed air bubbles will tend to collectin the hollow area defined by the alignment flange or tab member 156during operation of the injector head 3. As shown in FIG. 18, thecoupling members of the coupling end 164 of the plunger member 158 ofthe syringe 61 are positioned perpendicularly to the alignment flange ortab member 156. This syringe is configured for use with the injectorhead illustrated in FIGS. 3 and 4. Alternatively, the coupling members227 of the coupling end 164 of the plunger member 158 of the syringe 61′may be positioned parallel to the alignment flange or tab member 156 asshown in FIG. 22. This type of syringe is configured for use with theinjector head of FIG. 26.

With specific reference to FIGS. 23 and 24, prior art syringes formedical injection procedures are often stored with a pre-positionedsyringe plunger. A difficulty with current disposable plastic syringesis that these syringes exhibit plastic creep over time and especiallyduring sterilization heat cycles. This causes the plastic syringe toswell, particularly in a plunger area about the syringe plunger. Thisoften makes it difficult to load prior art plastic syringes in frontloading pressure jackets because of swelling in the plunger area wherethe syringe plunger is stored.

The syringe 61 of the device of the present disclosure stores theplunger member 158 in the expansion section 150 to accommodate theexpansion and plastic creep of the plastic syringe body 74 as discussedhereinafter. The expansion section 150 is desirably formed adjacent thecylindrical center section or main body 152 of the syringe body 74 andat the proximal end 76 of the syringe body 74. However, the expansionsection 150 may be formed or located at any position in the syringe body74 wherein the plunger member 158 is to be stored. At the expansionsection 150, a wall 166 of the syringe body 74 narrows from a thicknessT to a reduced wall thickness T_(r). Thus, an inner diameter ID_(es) ofthe expansion section 150 is larger than an inner diameter ID_(es) ofthe cylindrical center section or main body 152. The reduced wallthickness T_(r) at the expansion section 150 allows the expansionsection 150 to expand outward under the force exerted by the plungermember 158 without an outer diameter OD_(es) of the expansion section150 becoming larger than an outer diameter OD_(es) of the center section152 of the syringe body 74. Both an outer surface 168 of the wall 166 ofthe syringe body 74 and an inner surface 170 of the wall 166 of thesyringe body 74 taper or are stepped to form the reduced wall thicknessT_(r) at the expansion section 150. In particular, the outer surface 168of the wall 166 of the syringe body 74 is tapered or stepped inwardtoward the central axis L of the syringe body 74 and the inner surface170 of the wall 166 of the syringe body 74 tapers or is stepped outwardaway from the central axis L of the syringe body 74 to form the reducedwall thickness T_(r). An alternative configuration to the foregoing isto only taper or step the inner surface 170 of the wall 166 of thesyringe body 74 outward away from the central axis L of the syringe body74. Another alternative is to only taper or step the outer surface 168.

The reduced wall thickness T_(r) at the expansion section 150 of thesyringe 61 accommodates the expansion and plastic creep of the plasticsyringe body 74 even after long periods of storage. Thus, even aftersuch long storage periods, the syringe 61 with pre-positioned plungermember 158 may be quickly and easily inserted into front-loadingpressure jacket systems, such as pressure jacket assembly 63. As statedpreviously, the plunger member 158 is stored in the expansion section150. When the syringe 61 is inserted into the pressure jacket 65 andready for use, the plunger member 158 is engaged by the injector drivepiston in the manner discussed previously and moved forward from theexpansion section 150 to the center section or main body 152 of thesyringe 61, which may be referred to as the “working zone” of thesyringe 61.

With reference to FIGS. 18-20 and 25, the syringe 61 further includes aconnector 172 for coupling a patient tubing set 174 having a connectingportion 175 to the syringe 61. The connector 172 is configured to bepositioned over the injection neck 77 of the syringe 61. The connector172 includes a threaded portion 176 that cooperates with a threadedportion 178 on the syringe 61. The connector 172 includes a cooperatingslot 180 into which a flange 182 of the tubing set 174 slides to alignan inner passage (not shown) of the tubing set 174 with an opening (notshown) in the connector 172. The flange 182 cooperates with a retainingmember or flange 184 formed upon a forward end of the connector 172 anda forward abutment wall 186 on the connector 172 (which form the slot180 therebetween) to substantially prevent relative axialmovement/separation of the connector 172 and the tubing set 174 afterconnection thereof.

The retaining member 184 is desirably of a generally circular shape withan opening 188 therein. The opening 188 allows passage of a generallycylindrical portion 190 of the tubing set 174 therethrough when theconnector 172 and the tubing set 174 are connected. The width of theopening 188 is desirably somewhat smaller than the diameter of thegenerally cylindrical portion 190, such that the connecting portion 175of the tubing set 174 snaps into place when aligned with the connector172 and sufficient force is applied in the direction of arrow F.Alternatively, there may be a clearance provided between flange 182 andretaining member 184. The connector 172 is desirably fabricated from aresilient polymeric material, such as polycarbonate. In addition, theconnecting member 175 is desirably fabricated from a host of otherresilient polymeric materials and the tubing set 174 is desirablyfabricated from flexible polymeric materials of either single wall,coextruded, or braided designs.

After the tubing set 174 is connected to the connector 172, theconnector 172 is rotated relative to the injection neck 77 of thesyringe 61, such that a tapered end 191 of the injection neck 77 passesthrough the opening (not shown) in the connector 172 to mate with acorrespondingly tapered interior wall (not shown) on the rearwardportion of the tubing set 174 to form a fluid tight connection. Becausethe opening 188 is smaller than the cylindrical portion 190 of thetubing set 174, the retaining member 184 prevents disconnection of theconnector 172 and the connecting portion 175 of the tubing set 174 aftera fluid tight connection has been made. The connector 172 and the tubingset 174 are configured to remain in a connected state under allcircumstances and forces normally experienced before and duringconnection of the tubing set 174 to the syringe 61. Prior to use, a dustcover 192 may be provided over the connector 172 and injection neck 77to protect the contents of the syringe 61 from contamination.

Further details of the connector 172 are described in United StatesPatent Application Publication No. 2005/0171487, which is herebyincorporated by reference in its entirety.

With reference to FIGS. 3 and 4, the syringe support structure 69 isprovided for the purpose of constraining the syringe 61 duringpressurized injections. One embodiment of the syringe support structure69, as shown in FIGS. 3 and 4, includes at least one, and desirably two,support arms 79, 81 extending outward from the injector housing 53. Thesupport arms 79, 81 are configured to pivot up and down with respect tothe injector housing 53. The support arms 79, 81 have rear or proximalends extending into the injector housing 53, and distal ends projectingoutward from the injector housing 53. The distal ends of the supportarms 79, 81 are interconnected by a syringe retaining wall or member 83.The syringe retaining member 83 may be affixed to the support arms 79,81 by conventional mechanical fasteners (i.e., bolts) and the like. Thesyringe retaining member 83 defines a central syringe receiving slot 85that is substantially vertically oriented and is configured to receiveand support the injection neck 77 of the injection section of thesyringe 61. The syringe retaining member 83 further defines one or moreopenings 87, which are spaced radially outward from the syringereceiving slot 85. The syringe receiving slot 85 and openings 87 permitthe operator of the fluid injection system 1 to view the syringe 61during an injection procedure.

The support arms 79, 81 are generally configured to be movable between afirst position, wherein the syringe retaining member 83 receives theinjection neck 77 and cooperates with the injection section of thesyringe 61 and prevents removal of the syringe 61 from the pressurejacket 65, and a second rotated position wherein the injection neck 77and the injection section of the syringe 61 are disengaged sufficientlyfrom the syringe receiving slot 85 and syringe retaining member 83 toallow removal of the syringe 61 from the pressure jacket 65. Inparticular, in the second position, the injection neck 77 is disengagedsufficiently from the syringe receiving slot 85 and the injectionsection is sufficiently decoupled from the syringe retaining member 83to allow the syringe 61 to be removed easily from the front loadingpressure jacket 65. Desirably, in the second position, the support arms79, 81 and syringe retaining member 83 are spaced a distance below thepressure jacket 65 and syringe 61. With the support arms 79, 81 in thefirst position, the syringe support structure 69 is in a syringe-engagedposition. When the support arms 79, 81 are moved to the second position,the syringe support structure 69 is generally in a syringe-disengaged orremoval position or configuration. A removable heating element 86 (seeFIG. 2) may be attached to the pressure jacket 65 to keep the fluidprovided in syringe 61 pre-heated at 37° C.

An alternative embodiment of an injector head 3′ having an alternativesyringe support structure 69′ as illustrated in FIG. 26 allows thepivoting of syringe support structure 69′ sideways or rotatedapproximately 90 degrees from the previous embodiment shown in FIGS. 3and 4. More specifically, the syringe support structure 69′ includes atleast one, and desirably two, support arms 79′, 81′ extending outwardfrom a faceplate 57′ of an injector housing 53′. The support arms 79′,81′ are configured to pivot right and left with respect to the injectorhousing 53′. The support arms 79′, 81′ have rear or proximal endsextending into the injector housing 53′, and distal ends projectingoutward from the injector housing 53′. The distal ends of the supportarms 79′, 81′ are interconnected by a syringe retaining wall or member83′. The syringe retaining member 83′ may be affixed to the support arms79′, 81′ by conventional mechanical fasteners (i.e., bolts) and thelike.

In this alternative embodiment, the pivoting axis of the syringe supportstructure 69′ is largely vertical in nature as opposed to the previousembodiment where the pivoting axis is largely horizontal in nature. Thissecond embodiment has the distinct advantage of neutralizing the effectsof gravity associated with the previous embodiment. The structuralcomponents that make up the syringe support structure 69′ may containsubstantial mass and therefore may be heavily influenced by the effectsof gravity. This can lead to a drooping effect causing the syringesupport structure 69′ mechanism to fall away from its intended closedposition. The second embodiment combats this by ensuring the pivotingaction is largely perpendicular to the vector of gravitational pull.

Another distinct advantage of the second embodiment is the ability toassist with manipulating the injector head 3′. An essential component ofnormal use of the injector head 3′ is the ability to rotate it from thelargely upward fill/purge position to a largely downward injectionposition. This rotation is a common air management technique whereas theair is purged out of the syringe 61 in the upward position and thenrotated downward for the procedure. This is done to ensure anyun-expelled air remains trapped in the back of the syringe 61 and is notinjected into the patient. Users often grasp the back of the injectorhead 3′ with their left hand and the front of the injector head 3′ withtheir right hand to accomplish this rotating action. Grasping andpushing on the syringe support structure 69′ can potentially open thesyringe support structure 69′ because the rotation axis of the injectorhead 3′ is normal to the same plane as the rotation axis of the syringesupport structure 69′. The second embodiment eliminates this tendency toopen when pushed by ensuring the syringe support structure 69′ pivotsvia an axis that is largely perpendicular to axis of rotation of theinjector head 3′.

Yet another advantage of the second embodiment is superior resistance tocontrast fouling. The syringe support structure 69′ is comprised of manycomponents with a large number of crevices for contrast to get trappedin. Orienting the syringe support structure 69′ such that it pivotssideways prevents contrast from building up in some of the moreproblematic areas.

With reference to FIGS. 27 and 28, a splash shield 250 may be providedto cover the syringe retaining member 83′ of the syringe supportstructure 69′. During a typical angiography procedure, the user fillsthe syringe 61 with contrast while the injector head 3′ is in the upwardposition allowing the syringe 61 to point largely towards the ceiling.Once the desired amount of fluid is obtained, the user purges the airout of the syringe 61. With the syringe tip being the highest point, theair naturally rises to the top and escapes the syringe 61. Occasionally,the user spills some contrast onto the syringe support structure 69′during this filling or purging process, which can result in a phenomenonknown as contrast fouling. The purpose of the splash shield 250 is todivert any spilled contrast away from the syringe support structure 69′and into a more desirable location. One of the benefits of the splashshield 250 is that it snaps onto the syringe retaining member 83′ of thesyringe support structure 69′ in a very simple manner. It is held inplace by very specific geometry and cantilever beam undercut fingers252. This allows the user to remove the splash shield 250 for cleaningor replacement. Another benefit is that it can be manufactured from aclear polymeric material. This allows the user to maintain visibility ofthe syringe 61. It also allows light to pass through, maintaining a highlevel of syringe visibility. Increased visibility is important to theuser because they must verify that no air is trapped in the syringe 61prior to injection. The splash shield 250 may also be provided to coverthe syringe retaining member 83 of the syringe support structure 69 ofthe first embodiment discussed hereinabove.

With reference to FIGS. 43-45, this alternative embodiment of thesyringe support structure 69′ may be incorporated into a dual syringeinjector head having a first syringe support structure 69′ capable ofsupporting a first pressure jacket 65′ and syringe and a second syringesupport structure 69″ capable of supporting a second pressure jacket 65″and syringe. The first syringe support structure 69′ includes at leastone, and desirably two, support arms 79′, 81′ extending outward from afaceplate 57″ of the injector housing. The support arms 79′, 81′ areconfigured to pivot right and left with respect to the injector housing.The support arms 79′, 81′ have rear or proximal ends extending into theinjector housing, and distal ends projecting outward from the injectorhousing. The distal ends of the support arms 79′, 81′ are interconnectedby a syringe retaining wall or member 83′. The second syringe supportstructure 69″ also includes at least one, and desirably two, supportarms 79″, 81″ extending outward from the faceplate 57″ of the injectorhousing. The support arms 79″, 81″ are configured to pivot right andleft with respect to the injector housing. The support arms 79″, 81″have rear or proximal ends extending into the injector housing, anddistal ends projecting outward from the injector housing. The distalends of the support arms 79″, 81″ are interconnected by a syringeretaining wall or member 83″.

Such a dual syringe injector head allows for various modes of operationas discussed in greater detail in U.S. Pat. Nos. 8,133,203 and7,553,294, which are hereby incorporated by reference in their entirety.More specifically, the following modes of operation may be utilized bythe dual syringe injector: a mode for sequential injection from thesyringes, a mode for simultaneous injection from the syringes into asingle injection site and a mode for simultaneous injection from thesyringes into different injection sites.

In the case of a sequential injection, a fluid can be injected from onlyone of the syringes at a time. For example, the syringe associated withpressure jacket 65′ can contain contrast medium, while the syringeassociated with pressure jacket 65″ can contain a flushing fluid such assaline, which can be sequentially injected into a patient using avariety of protocols as known in the art.

During simultaneous injection into a single site, the syringe associatedwith pressure jacket 65′ can, for example, be loaded or filled withcontrast medium, while the syringe associated with pressure jacket 65″can, for example, be loaded with a diluent or flushing fluid such assaline. In this mode, contrast medium or other fluid in the syringeassociated with pressure jacket 65′ can, for example, be diluted ormixed with fluid in the syringe associated with pressure jacket 65″ to adesired concentration by simultaneous injection from the syringeassociated with pressure jacket 65′ and the syringe associated withpressure jacket 65″ as programmed by the operator.

In the case of a simultaneous injection to different injection sites,the syringe associated with pressure jacket 65′ and the syringeassociated with pressure jacket 65″ can, for example both be filled withthe same injection fluid (for example, contrast medium). Injection ofthe contrast medium at two different sites, as opposed to a single site,can, for example, enable delivery of a desired amount of contrast mediumto a region of interest at a lower flow rate and a lower pressure ateach site than possible with injection into a single site. The lowerflow rates and pressures enabled by simultaneous injection into multiplesites can, for example, reduce the risk of vascular damage andextravasation.

With continuing reference to FIGS. 2-4, the injector housing 53 includesa piston (not shown) positioned therein for connecting and actuating theplunger member 158 of the syringe 61. An actuation system (not shown) isalso positioned within the injector housing 53 for moving the piston.The actuation system may include a gear train and linear ball screw; abrushless DC motor coupled to the gear train and linear ball screw; anda motor amplifier operationally coupled to the motor as is known in theart. A controller (not shown) internal to the injector housing 53,controls piston movement via the brushless DC motor. Syringe filling andinjections of contrast agents are controlled by this controller. Thecontroller communicates with the operator via the graphical userinterface of the DCU 9. The injector housing 53 also includes a display88 for displaying information regarding the activities and state ofoperation of the injector head 3. The display 88 is positioned on a topportion of the injector housing 53 and displays information regardingvolume remaining, programmed flow rate, programmed pressure, andprogrammed volume. Each of these items may be presented to the operatoron the display by an independent light emitting diode (LED) display. Forinstance, volume remaining may be displayed on LED display 88 a,pressure may be displayed on LED display 88 b, programmed volume may bedisplayed on LED display 88 c, and flow rate may be displayed on LEDdisplay 88 d (see FIG. 3). The injector housing 53 further includes aknob 90 positioned at a back end 56 thereof. The knob 90 is an externalmanual device directly coupled to the injector head actuation system.The knob 90 allows the user to move the piston manually in either theforward or reverse direction. Accordingly, the purpose of the knob 90 isto allow an operator to: (1) manually purge air out of the syringe 61;and (2) retract (or extend) the syringe plunger in the event of a systempower failure so as to allow for installation or removal of the syringe61. A handle 92 is also positioned on injector housing 53 forrepositioning or transporting the fluid injection system 1.

With reference to FIGS. 29 and 30 and continued reference to FIGS. 3 and4, various sensors are also provided within the injector housing 53. Forinstance, the fluid injector system 1 employs a method of thermalmanagement that prevents the system from being damaged due to thermaloverload of the electronics and motor drive. Accordingly, four (4)thermal sensors are used within the injector housing 53 to measure thetemperature at strategic locations. Two temperature sensors 89 a, 89 bare mounted on a motor drive printed circuit board (PCB) 91. Thesetemperature sensors 89 a, 89 b measure the temperature of powertransistors below heat sinks on the motor drive PCB 91. Anothertemperature sensor 93 is mounted on the underside of a head display PCB95, which is mounted directly over the motor drive PCB 91. The purposeof this temperature sensor 95 is to measure the heat plume generatedabove the heat sinks of the power transistors. A final temperaturesensor 97 is mounted on a signal management PCB 99. The purpose of thistemperature sensor 97 is to measure the injector housing ambienttemperature. Those of skill in the art will appreciate that theplacement and linking together of multiple temperature sensors can varywhile achieving the same result.

The four sensors 89 a, 89 b, 93, 97 are interfaced to analog to digitalconverters and are read by the controller mounted within the injectorhousing 53. Software provided on the controller continuously monitorsthe temperature signal provided by each sensor 89 a, 89 b, 93, 97. Thesoftware is programmed with predefined limits for which it will inhibitmotor amplifier operation if these limits are exceeded. The primarysource of heat during a high pressure injection procedure is due to thehigh amounts of power delivered to the motor via the motor amplifier.During the design of fluid injection system 1, each of the electricalcomponents is derated to produce the derated component value. Thisderating process is as follows. The performance parameters of acomponent (e.g., maximum power dissipation, maximum voltage, etc.) arespecified by manufacturers. To improve reliability of a product anddecrease probability of device or component failure, engineers typicallyapply derating criteria during the design so that components will neveroperate at the maximum ratings. For example, a resistor may have amaximum power dissipation of 0.5 Watts. If this value is derated by 50%,then the maximum power it will ever dissipate is 0.25 Watts. Suchderating drastically improves product reliability. The predefined limitsdiscussed above are based on derated component values, so that if aninjection is started and the temperature exceeds the predefined limit,there is substantial headroom to allow the injection to complete,without exceeding the absolute maximum working temperature of theweakest component in the fluid injection system 1. Any suitabletemperature sensor may be used for this purpose. Desirably, thetemperature sensors 89 a, 89 b, 93, 97 are 1.5V, SC70, Multi-Gain AnalogTemperature Sensors with Class-AB Output (Part No. LM94022/LM94022Q)manufactured by National Semiconductor Corporation.

In addition and as discussed hereinabove, the fluid injection system 1may be provided in one of two different configurations: a mobilepedestal, as shown in FIG. 1A; and a fixed examination table-railconfiguration that allows the operator to attach both the injector head3 and the DCU 9 to the rail of the examination table, as shown in FIG.1B.

Many examination table and bed manufacturers offer beds that have lift,pan, and tilt functionality, allowing the physician to position thepatient three-dimensionally in a surgical suite. Accordingly, athree-axis accelerometer 101 is provided on signal management PCB 99 toallow the fluid injection system 1 to establish a reference plane withrespect to the room floor surface. The output signal of theaccelerometer 101 is read by the controller provided in the injectorhousing 53 to first determine if there is an offset in the coordinatesystem of the accelerometer 101 and in which axis of the Cartesiansystem this offset exists. If the offset is detrimental to airmanagement, then the operator is alerted via a message provided on thegraphical user interface of DCU 9 to reposition the injector head 3 orthe entire fluid injection system 1 to a normal surface parallel to thefloor.

The three-axis accelerometer 101 is a Micro-Electro-Mechanical (MEMS)integrated circuit (IC) that is sensitive to accelerative forces withearth gravity being the primary force of interest. Any suitablethree-axis accelerometer 101 may be utilized. For instance, theaccelerometer 101 may be a three-axis low-g micromachined accelerometer(Part No. MMA7361LC) manufactured by Freescale Semiconductor.

In addition, several other sensors may be provided in the injector head3 to provide signals to the controller so that it can be determined ifthe syringe 61 has been loaded, if the syringe retaining wall 83 hasbeen properly positioned, if the plunger has been sufficiently advanced,and/or the angle of tilt of the injector head 3. The determination ofthe tilt angle of the injector head 3 will be discussed in greaterdetail hereinafter.

With reference to FIGS. 31-40 and continued reference to FIGS. 3 and 4,as discussed hereinabove, the knuckle 22 pivotally supports the injectorhead 3 on the second support arm 19, thereby allowing the injector head3 to rotate around the axis labeled X in FIG. 1A. The knuckle 22includes an L-shaped body portion 102 having a pivot post 103 and ahollow coupling post 104 positioned perpendicularly to the pivot post103. The pivot post 103 is pivotally connected to the second end 20 ofthe second support arm 19, thereby allowing the injector head 3 torotate around the axis labeled Y in FIG. 1A. A connection post 105 isprovided having a first end that extends into the coupling post 104 anda second end that is coupled to a bracket 106. The bracket 106 iscoupled to the injector head 3 within the injector housing 53, as shownin FIG. 29. This configuration allows the injector head 3 to rotatearound the axis labeled X in FIG. 1A while being supported by theconnection post 105.

Current fluid injection systems typically require the use of a sensorthat determines the angle of tilt of the head relative to the directionof Earth gravitation using an accelerometer (see, for instance, U.S.Pat. No. 5,868,710). The fluid injection system 1, however, incorporatesa device into the knuckle 22 that is used to determine the angularposition of the injector head 3 with respect to the support column 17instead of relative to the direction of Earth gravitation. This deviceincludes a potentiometer 107 that is mounted on a PCB 108 inside theinjector head 3 at the location where the injector head 3 interfaceswith the knuckle 22. More specifically, and as shown in FIGS. 32, 34,and 36, the PCB 108 and potentiometer 107 are positioned at the secondend of the connection post 105.

The potentiometer 107 is a three-terminal electrical device whose centerterminal is connected to a wiper mechanism. The other terminals areconnected on opposite ends of a resistor surface internal to thepotentiometer 107. The wiper mechanism is free to move across theresistive surface. When a voltage is applied across the two outerterminals, the center terminal output is proportional to the position ofthe wiper. The output of the potentiometer 107 is an angular dependentvoltage that is sent to an analog to digital converter (ADC). The signalproduced by the ADC is read by the controller provided within theinjector housing 53 of the injector head 3. The potentiometer 107 may beany suitable potentiometer based rotary position sensor, such as the3382-12 mm Rotary Position Sensor manufactured by Bourns or the SMD/LeadDust-proof Type 12 mm Size SV01 Series Rotary Position Sensormanufactured by Murata. Alternatively, other electrical devices, suchas, but not limited to, an encoder or a mechanical or optical switchmatrix may be used in place of the potentiometer 107.

Accordingly, the potentiometer 107 provided in knuckle 22 is used toprovide the controller of the system with an indication of the positionof the injector head 3. Head position or tilt sensing is an importantsafety feature that allows the controller to enforce air management inthe syringe 61. When syringe 61 is filled, air within the syringe 61 isdisplaced by contrast, however, not all of the air is removed. Fillingshould always be performed with the injector head 3 pointed in avertical direction as shown in FIG. 38. The orientation of the knuckle22 during a filling stage is shown in FIGS. 33 and 34. This keeps theresidual air at the top of the syringe 61. Once filled, the syringe 61must be purged of air in the vertical position. In addition, when thesyringe 61 is filled and ready for injection, the injector head 3 mustbe tilted down as shown in FIG. 37. The orientation of the knuckle 22during an injection stage is shown in FIGS. 31 and 32. The controller,based on a signal received from the potentiometer 107, tracks theposition of the injector head 3 at all times. If the injector head 3 ispointed up, the controller will not allow the fluid injection system 1to arm and inject.

The tilt position signal provided by the potentiometer 107 also controlsthe head display 88. The operation of the head display 88 can beunderstood with reference to FIG. 40. Specifically, as noted above, thecontroller receives a signal from the potentiometer 107 indicative ofthe angle of the injector head 3 relative to the support column 17. Thecontroller repeatedly samples this signal and determines the angle ofthe injector head 3 relative to the support column 17. All possibleangles of rotation are divided into three regions of operation,illustrated in FIG. 40.

Region 1 is the “purge” region where the angle at which the injectorhead 3 should be placed for purging the syringe. When the injector head3 is at an angle within region 1 (from +55° to when the head is pointingstraight up at +80°), the injector head 3 will permit hand-operatedmotion of the plunger drive ram in either the forward or reversedirection, allowing the operator to remove air from the syringe afterinitial filling, thereby purging the system. This is the only validpurge area where the software will recognize a purge. When the injectorhead 3 is moved into region 2 (from −10° to +55°), the system can bepurged; however, the system does not recognize the purge as valid andwill alert the user via the “Smart Sentinel” system discussedhereinafter. In addition, the syringe can also be filled when theinjector head 3 is at an angle within region 1, or within region 2. Awide range of movement speeds can be generated, permitting rapid fillingof the syringe. While the injector head 3 is in region 1, however,programmed injections are inhibited as described hereinabove. Thus, theoperator cannot initiate injection of a subject according to apre-programmed injection protocol while the injector head 3 is in anupright position. This minimizes the likelihood of accidental injectionof air into the subject.

Region 3 is the “inject” region (from −10° to when the head is pointingstraight down at −90°). When the injector head 3 is tilted in thisregion, programmed injections can be initiated. Furthermore, a controlbutton 109 provided on the top of the injector housing 53 (see FIGS. 3and 4) can be used to move the piston in either the forward or reversedirections; however, the range of movement speeds that can be generatedwith the control button 109 is substantially narrowed as compared tothose available in regions 1 or 2. This permits fine-tuned control offluid injection (or withdrawal of blood, e.g., to check patency of thecatheter) using the control button 109.

The various angular regions noted above, are also associated withdisplay orientations. Specifically, as can be seen in FIG. 40, thedisplay 88 of the injector head 3 includes several independent lightemitting diode (LED) displays. For instance, and as describedhereinabove, volume remaining may be displayed on LED display 88 a,programmed pressure may be displayed on LED display 88 b, programmedvolume may be displayed on LED display 88 c, and programmed flow ratemay be displayed on LED display 88 d. A volume remaining icon 110 mayalso be provided on display 88. This volume remaining icon 110 is onlyilluminated when the injector head 3 is positioned within region 3. Thevolume remaining icon 110 provides the operator with a quick indicationthat there is still a volume of a fluid remaining in the syringe if thisicon is illuminated, whereas the actual volume remaining in the syringe(e.g., 150 mL) is displayed on the volume remaining LED display 88 a.The LED displays are arranged so the noted information can be displayedin either a first (see element 200) or second (see element 300)orientation. When the injector head 3 is in the inject position (down),all of the LED displays are illuminated, as shown by element 300 (i.e.,the second orientation). When the injector head 3 is oriented in aFill/Purge position (up), only the Volume Remaining LED display 88 a isilluminated, as shown by element 200 (i.e., the first orientation).

The controller in the injector head 3 drives the various LED displays ofthe display 88 to produce the display orientation using the LED displaysin the manner illustrated by element 200, when the tilt angle is inregion 1. Otherwise, in regions 2 and 3, the controller drives thevarious LED displays of display 88 to produce the display shown byelement 300. As a result, the information appearing on the display 88 isalways upright from the perspective of the operator, facilitating use ofthe display.

The installation and operation of the fluid injection system 1 will nowbe discussed. Prior to turning on the fluid injection system 1, a sourceof power 41, such as 110 or 220 volts of electricity sent through a linecord 43 from a wall socket (not shown), is provided to the fluidinjection system 1. Thereafter, the operator turns on a master powerswitch (not shown), preferably situated on the power supply unit 39 ofthe fluid injection system 1. The fluid injection system 1 respondsthrough visual indicia, such as the illumination of a green light (notshown) on the injector head 3, to indicate that the fluid injectionsystem 1 has line power applied to the system power supply. The operatorthen turns on system power via a power switch (not shown) on the DCU 9.It is to be understood that the DCU 9 may be turned on automaticallywhen the master power switch of the fluid injection system 1 is turnedon. After power has been supplied to the DCU 9, the fluid injectionsystem 1 responds by undergoing various self-diagnostic checks todetermine if the fluid injection system 1 exhibits any faults orconditions that would prevent proper operation of the fluid injectionsystem 1. If any of the self-diagnostic checks fail and/or a fault isdetected in the fluid injection system 1, a critical error window orscreen is displayed on DCU 9, which may instruct the operator to contactservice personnel to remedy the fault or instruct the operator on how toremedy the fault himself or herself. Additionally, the fluid injectionsystem 1 will not allow an operator to proceed with an injection if anyof the self-diagnostic checks have failed. However, if allself-diagnostic checks are passed, the fluid injection system 1 proceedsto display a main control screen on the DCU 9.

With reference to FIGS. 41 and 42, a main control screen 112 includesvarious on-screen controls, such as buttons, that may be accessed by theoperator via the touch-screen graphical user interface of the DCU 9. Theon-screen controls may include, but are not limited to, selectableoptions, menus, sub-menus, input fields, virtual keyboards, etc. Theoperator may therefore utilize the touch-screen of the DCU 9 to programone or more injection cycles of the fluid injection system 1 and todisplay performance parameters. It is to be understood that input to theDCU 9 may also be accomplished by providing an on-screen cursor andexternal pointing device, such as a trackball or mouse, that isoperatively associated with the on-screen cursor. It is to be understoodthat the operator may stop any automatic functions of the fluidinjection system 1 by touching an “Abort” button.

Once the fluid injection system 1 initializes, the user presses a“Continue” button (not shown) on the DCU 9. At this point, the maincontrol screen 112 will include a “Smart Sentinel” box 114. The “SmartSentinel” box 114 includes a list of actions on the main control screen112 that must be completed by the operator before the injector head 3can be armed to perform an injection procedure. This list of actions isbased on input provided by one or all of the sensors positioned in theinjector head 3 as described hereinabove. For instance, the list ofactions may include load syringe, engage drop front, advance plunger,rotate injector head down to arm, rotate syringe and remove, disconnectpatient, flow rate reduced, calibration needed, rotate head up andpurge, injection complete, procedure halt—display touch, procedurehalt—head touch, procedure halt—start switch, procedure halt—ISI, andprocedure halt—low volume. However, this list is not to be construed aslimiting the device of the present disclosure as it has been envisionedthat a variety of other actions may be included in the “Smart Sentinel”box 114.

As discussed in greater detail hereinabove, the injector head 3 includesa variety of different sensors to provide a signal to the controller todetermine if a syringe has been loaded, if the syringe retaining wall 83has been properly positioned, if the plunger has been properly advanced,and/or the position of the injector head 3. Once a sensor provides asignal to the controller that the operator has completed an action fromthe list of actions, the action is removed from the list of actions onthe DCU 9. Once all of the actions have been completed, the “SmartSentinel” box 114 disappears as shown in FIG. 42 and the operator canarm the injector head 3. If any of the items remain in the “SmartSentinel” box 114, the operator is prevented from arming the injectorhead 3 and an injection procedure cannot be performed. This feature hasthe advantage of adding clarity to the user interface and reducinginteractions with the fluid injection system 1, increasing thelikelihood that a user will have a successful interaction with the fluidinjection system 1 and generate the desired outcome.

Returning to the operation of the fluid injection system 1, after theoperator has reached the main control screen 112, the operator tilts theinjector head 3 up so that it is in region 1, as discussed hereinabove.A syringe 61 is then installed by inserting the syringe into thepressure jacket 65 and raising the syringe support structure 69. Oncethe syringe is successfully installed, the listings of the notices toload the syringe and to engage the drop front of the syringe supportstructure 69 in the “Smart Sentinel” box 114 are automatically removedtherefrom. In addition, the piston of the actuation system of theinjector head 3 is then moved forward 150 mL to remove all air from thesyringe 61. Once the piston has been advanced, the listing providingnotice to advance the plunger in the “Smart Sentinel” box 114 isautomatically removed therefrom, such that the only action remaining inthe listing of actions in the “Smart Sentinel” box 114 is the notice torotate the head down to arm.

The syringe 61 may now be initially filled with contrast media byremoving the dust cap from the syringe 61 and installing a first end ofa “quick fill” tube (not shown) on the syringe 61. A second end of the“quick fill” tube is inserted into an open contrast bottle (not shown)and the syringe 61 is filled. The syringe 61 may be filled automaticallywhen the operator touches a “Fill Contrast” button on the DCU 9, whichcauses the fluid injection system 1 to enter an auto-fill mode. In theautomatic fill mode, the fluid injection system 1 moves the injectorpiston proximally at a controlled rate, such as 3 mL/s, which causescontrast media to be drawn from the contrast bottle. The fluid injectionsystem 1 may provide visual feedback of this action to the operator viathe DCU 9, such as by an iconic representation 116 of the syringe 61shown on main control screen 112. Thus, the fluid injection system 1 maydisplay on the DCU 9 the current volume in the syringe 61 based upon theposition of the injector piston. The fluid injection system 1 proceedsto draw contrast from the contrast bottle until a predetermined eventoccurs, such as when the total remaining volume in the syringe 61reaches a preset or pre-chosen amount or the contrast media volume inthe contrast container is depleted completely. Alternatively, thesyringe 61 may be filled manually by retracting the injector pistonusing the control button 109 provided on the injector head 3.

Thereafter, the fluid injection system 1 is configured to undergo apurge of air from the filled syringe 61. This is accomplished bymanually rotating the knob 90 to advance the injector piston, therebypurging any air remaining from the filled syringe 61. The operator mayfacilitate the removal of any remaining trapped air by tapping the bodyof the pressure jacket 65 and the syringe 61 to dislodge any air bubblesthat may be stuck to the side of the syringe 61. It is to be understoodthat the purging operation may be repeated as necessary to ensure thatall air is expelled from the syringe 61. Thereafter, the “quick fill”tube is removed and the dust cover is placed back on the syringe untilit is ready for an injection procedure.

At this point, the fluid injection system 1 is ready to accept theinstallation of a disposable tubing set 118 (see FIG. 2). Specifically,the operator removes the dust cap from the syringe 61 and removesdisposable tubing set 118 from its package. Then, the operator maysecure the patient end of the disposable tubing set 118 to anexamination table or other securing point. Thereafter, the operatorconnects the other end of the disposable tubing set 118 with theinjection neck 77 of the syringe 61.

The operator then advances the injector piston by rotating the knob 90to fill the disposable tubing set 118 with contrast from the syringe 61.The operator then rotates the injector head 3 downward until it reachesa position provided in region 3, as discussed hereinabove. Once theinjector head 3 is rotated down, the listing of rotate head down to armin the “Smart Sentinel” box 114 is automatically removed therefrom andthe “Smart Sentinel” box 114 is removed from the main control screen, asshown in FIG. 42. In addition, an alert may be provided to the operatorthat all of the actions in the “Smart Sentinel” box 114 have beencompleted. This alert may be accomplished through either audio or visualindicia, such as a beep or an on-screen alert message, respectively.Thereafter, a wet-to-wet connection is performed by moving the knob 90forward while connecting the patient end of the disposable tubing set118 to the patient catheter.

Once the fluid injection system 1 is correctly connected to the patient,the operator enters the flow rate, volume, pressure (if necessary), andrise time (if necessary) for the injection procedure on the graphicaluser interface of the DCU 9. Alternatively, the fluid injection system 1may maintain pre-programmed fluid delivery programs, (i.e., protocols),stored therein. Thus, instead of manually entering the desired flowrate, volume, pressure limit, and rise time for each injection cycle,the operator may program and store protocols, and recall previouslystored protocols corresponding to injection elements, such as thedesired flow rate, volume, pressure limit, and rise time. In anexemplary embodiment, a protocol is programmed and recalled via theon-screen controls of the DCU 9. After entering the appropriate valuesfor a protocol, the operator may store the protocol into any availablememory position of the fluid injection system 1 for future use of theprotocol in other injection cycles with other patients. The operator mayrecall any previously stored protocol from the memory of the fluidinjection system 1. In addition, the saved protocols may be sorted bydate.

After the desired flow rate, volume, pressure, and rise time have beenentered, either manually or automatically from a stored protocol, theoperator arms the injector by pressing an appropriate “ARM” button 120or 121 on the main control screen 112. This causes a pop up to appear onthe main control screen 112 requesting a confirmation that all air hasbeen expelled. Once the operator confirms that all air has beenexpelled, the fluid injection system 1 is armed. When ready, theoperator initiates the injection by activating either the hand/footswitch 51 or, if the injector is connected to a scanner, ISI initiation.Upon initiation of the injection procedure, the injector piston movesforward, thereby causing the contrast media to flow until the programmedvolume, as specified by the operator or the protocol, is delivered. Theinjector piston then ceases forward movement and the injection procedureis completed.

It is to be understood that the fluid injection system 1 may exist ineither an armed or unarmed state, which corresponds respectively towhether or not the operator is allowed to perform an injection. Thefluid injection system 1 may enter a disarmed or safe state when certainconditions are met including, but not limited to, failure of aself-diagnostic check, absence of some of the requisite components, andthe reaching of a pressure limit that is deemed to be unsafe for thepatient. The converse of these conditions and/or other factors must bepresent for the fluid injection system 1 to enter the armed state. Thefluid injection system 1 may provide various visual and/or audiblealarms to the operator to identify specific conditions that arise duringthe functioning of the fluid injection system 1. Such conditions mayinclude, but are not limited to, the arming/disarming of the fluidinjection system 1 and the state thereof and the reaching of a pressuredisarm limit.

In addition, there are instances where it is desirable to use the fluidinjection system 1 with high viscosity contrast agents and highlyrestrictive ID catheters (e.g., 4F OD and smaller). In such situations,the use of the fluid injection system 1 results in a significant amountof pressure in the disposable set (i.e., the catheter, syringe, etc.) atthe end of the injection procedure. To cope with the pressure remainingat the end of an injection, the fluid injection system 1 describedhereinabove monitors the pressure remaining and, when that pressuredrops below a predetermined threshold value, executes an algorithm toremove the remaining pressure from the system. This is done in such away as to minimize controlled recoil and maximize the amount of contrastdelivered as a percentage of programmed volume.

While specific embodiments of the device of the present disclosure havebeen described in detail, it will be appreciated by those skilled in theart that various modifications and alternatives to those details couldbe developed in light of the overall teachings of the disclosure.Accordingly, the particular arrangements disclosed are meant to beillustrative only and not limiting as to the scope of the device of thepresent disclosure which is to be given the full breadth of the claimsappended and any and all equivalents thereof.

1.-38. (canceled)
 39. A fluid injection system comprising: an injectorhead for delivering a fluid to a patient; a plurality of sensorspositioned within the injector head for generating signals indicative ofthe status of the injector head; a control system operationally coupledto the injector head and the plurality of sensors for controlling aninjection procedure; and a display unit operationally coupled to thecontrol system, wherein, based on the signals generated by the pluralityof sensors, the control system generates a list of actions on thedisplay unit that must be completed by a user before the injector headcan be armed to perform the injection procedure.
 40. The fluid injectionsystem of claim 39, wherein, as one of the plurality of sensorsdetermines that the user has completed an action from the list ofactions, the action is removed from the list of actions on the displayunit.
 41. The fluid injection system of claim 39, wherein the list ofactions is provided in a box displayed on the display unit.
 42. Thefluid injection system of claim 41, wherein the box is removed from thedisplay unit when every action on the list of actions has beencompleted.
 43. The fluid injection system of claim 39, wherein theplurality of sensors comprise at least one of: a sensor configured toprovide a signal to the control system to determine if a syringe hasbeen loaded into the injector head; a sensor configured to provide asignal to the control system to determine if a syringe retaining wall ofthe injector head has been properly positioned; a sensor configured toprovide a signal to the control system to determine if a plunger of thesyringe has been advanced; a sensor configured to provide a signal tothe control system of a position of the injector head.
 44. The fluidinjection system of claim 39, wherein the list of actions includes atleast one of the following actions: load syringe, engage drop front,advance plunger, rotate injector head down to arm, rotate syringe andremove, disconnect patient, flow rate reduced, calibration needed,rotate head up and purge, injection complete, procedure halt —displaytouch, procedure halt—head touch, procedure halt—start switch, procedurehalt—ISI, and procedure halt—low volume.
 45. The fluid injection systemof claim 39, wherein the display unit has a graphical user interface forallowing the user to control the injection procedure and for displayingthe list of actions.
 46. The fluid injection system of claim 45, whereinthe graphical user interface comprises a first area with at least onebutton for sending a signal to the control system to arm the injectorhead and a second area for displaying the list of actions.
 47. The fluidinjection system of claim 46, wherein the at least one button isinoperable until each action in the list of actions has been completedby the user.
 48. The fluid injection system of claim 39, wherein thecontrol system alerts the user when every action on the list of actionshas been completed.
 49. The fluid injection system of claim 39, furthercomprising a mounting structure pivotally connected to the injector headand configured to support the injector head.
 50. The fluid injectionsystem of claim 49, wherein the mounting structure comprises: a mobilebase positioned on a floor; a pole extending from the mobile base abovethe floor; and a first support arm having a first end pivotally coupledto the pole and a second end pivotally coupled to the injector head. 51.The fluid injection system of claim 49, wherein the mounting structurefurther comprises a second support arm having a first end pivotallycoupled to the pole and a second end pivotally coupled to the displayunit.
 52. A method of controlling an injection procedure comprising:providing a fluid injection system comprising: an injector head fordelivering a fluid to a patient; a plurality of sensors positionedwithin the injector head for generating signals indicative of the statusof the injector head; a control system operationally coupled to theinjector head and the plurality of sensors for controlling an injectionprocedure; and a display unit operationally coupled to the controlsystem, generating a list of actions, based on the signals generated bythe plurality of sensors, that must be completed by a user before theinjector head can be armed to perform the injection procedure;displaying the list of actions on the display unit.
 53. The method ofclaim 52, further comprising removing an action from the list of actionson the display unit as one of the plurality of sensors determines thatthe user has completed the action from the list of actions.
 54. Themethod of claim 52, wherein the list of actions is provided in a boxdisplayed on the display unit; and the method further comprises:removing the box from the display unit when every action on the list ofactions has been completed.
 55. The method of claim 52, wherein the listof actions includes at least one of the following actions: load syringe,engage drop front, advance plunger, rotate injector head down to arm,rotate syringe and remove, disconnect patient, flow rate reduced,calibration needed, rotate head up and purge, injection complete,procedure halt—display touch, procedure halt—head touch, procedurehalt—start switch, procedure halt—ISI, and procedure halt—low volume.56. The method of claim 52, wherein the display unit has a graphicaluser interface for allowing the user to control the injection procedureand for displaying the list of actions.
 57. The method of claim 56,wherein the graphical user interface comprises a first area with atleast one button for sending a signal to the control system to arm theinjector head and a second area for displaying the list of actions. 58.The method of claim 57, wherein the at least one button is inoperableuntil each action in the list of actions has been completed by the user.